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Enablement Issues in Pharmaceutical Claims

2. Overview. Challenge of Broad Compound ClaimCompound Enablement Considerations/In re WandsEnabled vs. Non-enabled InventionCompound Examples Support of DisclosurePossible Ways to Rebut RejectionComposition and ?method of use" examples. 3. Typical Compound Claim. Claims are directed to a b

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Enablement Issues in Pharmaceutical Claims

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    1. 1 Enablement Issues in Pharmaceutical Claims Joseph K. McKane Supervisory Patent Examiner Art Unit 1626 571-272-0699 Ardin Marschel Supervisory Patent Examiner Art Unit 1614 571-272-0718

    2. 2 Overview Challenge of Broad Compound Claim Compound Enablement Considerations/In re Wands Enabled vs. Non-enabled Invention Compound Examples Support of Disclosure Possible Ways to Rebut Rejection Composition and “method of use” examples

    3. 3 Typical Compound Claim Claims are directed to a broad genus of compounds including “R” groups, variables, and other types of combinations and permutations which are defined around some type of core structure. - Example - Markush type claim. - Multiple variable core – core may be a heterocyclic ring consisting of oxygen, nitrogen, sulphur and carbon atoms in different positional combinations.

    4. 4 Examiner/Applicant Challenge How can we limit the scope of the allowed genus of compounds so that it provides reasonable protection for applicant’s invention? Is there unpredictability/undue experimentation in today’s drug discovery?

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